Z-0380-2022 Class II Terminated
FDA device recall Z-0380-2022 was initiated by Ossur Americas on November 9, 2021 and is designated Class II. Reason for recall: Instructions for use were updated to include additional information to facilitate the selection and use of the collar device. The recall status is terminated (terminated December 18, 2023).
Recall Details
- Product Type
- Devices
- Report Date
- December 22, 2021
- Initiation Date
- November 9, 2021
- Termination Date
- December 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
Reason for Recall
Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.
Distribution Pattern
US Nationwide distribution in the states of CA, NH, CT, RI, MA, FL, DE, NY, NJ, PA, OH, DC, MD, VA, NC, SC, GA, MS, LA, TN, TX, KY, IN, AZ, MI, WI, MN, IL, IA, MO, NE, MT, ID, CO, NM, WA, OR, NV, UT, KS, AK, VT, AR, OK, AL, SD, WV, PR.
Code Information
Instructions for Use Rev. 3 2018